After the deaths of 13 patients taking Reminyl ( Galantamine ) during two investigational studies, drug's prescribing information has been updated.

In two randomized, placebo-controlled trials of 2 years duration in subjects with mild cognitive impairment ( MCI ), a total of 13 subjects on Reminyl ( n=1026 ) and 1 subject on placebo ( n=1022 ) died.
About half of the Reminyl deaths appeared to result from various vascular causes ( myocardial infarction, stroke, and sudden death ).

Although the difference in mortality between Reminyl and placebo-treated groups in these two studies was significant, the results are highly discrepant with other studies of Reminyl.

In these two MCI studies, the mortality rate in the placebo-treated subjects was markedly lower than the rate in placebo-treated patients in trials of Reminyl in Alzheimer’s disease or other dementias ( 0.7 per 1000 person years compared to 22-61 per 1000 person years, respectively ).

Although the mortality rate in the Reminyl-treated MCI subjects was also lower than that observed in Reminyl-treated patients in Alzheimer’s disease and other dementia trials ( 10.2 per 1000 person years compared to 23-31 per 1000 person years, respectively ), the relative difference was much less. When the Alzheimer’s disease and other dementia studies were pooled ( n=6000 ), the mortality rate in the placebo group numerically exceeded that in the Reminyl group.

Furthermore, in the MCI studies, no subjects in the placebo group died after 6 months, a highly unexpected finding in this population.

Source: FDA, 2005


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